Clinical research is the critical step in moving from laboratory studies to patient treatment and eventually to public health practice. Because of the interaction involved with patients or study participants, clinical research entails a range of issues quite different from those with which investigators involved in basic research must contend. A major issue is recruiting study participants—an issue that the Research Participant Registry was created to address. In addition, here are some other topics to consider:
How will participants be recruited for a study (particularly if a specific subset of the population is being targeted)?
What marketing or publicity tools will be most effective in reaching the study’s target audience?
How much it will cost you to advertise the study?
Will it be possible to recruit enough study participants?
Do study participants understand that their involvement is voluntary and that they can withdraw from a study at any time?
Are informed consent documents written in clear, understandable language? (For information about informed consent, see Ethical Considerations for Clinical Research.)
Are you using the current IRB-approved informed consent forms at all times?
Are the risks to study participants clearly described?
Are the steps to minimize risks to study participants being carried out as detailed in the informed consent document?
Likewise, are the steps to ensure the privacy and confidentiality of the study participants being adhered to as spelled out in the informed consent form?
Are payments to study participants reasonable to achieve the desired recruitment results?
Have you set up a WePay card for study participants?
Have all conflicts of interest been addressed?
Do you know what help with any of these issues is available from CTSI and how to access that help?
